91桃色

ISSN: 2155-9872

Journal of Analytical & Bioanalytical Techniques
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Focus on Challenges in Regulated Bioanalysis; Case Studies

International Conference & Exihibition On Analytical and Bioanalytical Techniques - 2010

D. Vijaya Bharathi

ScientificTracks Abstracts: J Anal Bioanal Techniques

DOI:

Abstract
Guidance from various regulatory authorities has helped significantly in the standardization of how to approach about regulated quantitative bioanalysis of small molecules. However there are some interpretation differences which are leading to dissimilar practices among bioanalytical scientists. Good scientific rationality must exist and assessment performed should be case specific. There are many hot topics viz, Ion Suppression, Matrix Effect, Contamination Criteria, multi analytes, failed run investigation, Regression Type, Stability, Repeats and ISR. Impact of above said areas on outcome of the bioequivalence study was incorporated in the current presentation in the form of case studies.
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